Process Support

Compliance Solutions

FAQ

Process:
A systematic series of actions directed to some end: a continuous
action, operation, or series of changes taking place in a definite
manner.

Support:
To bear or hold up (a load, mass, structure, part, etc.); serve as
a foundation for. To sustain or withstand (weight, pressure,
strain, etc.) without giving way; serve as a prop for.

Compliance:
Compliance is either a state of being in accordance with
established guidelines, specifications, or legislation or the
process of becoming so.

Solutions:
The method or process of solving a problem.

Thermal Validation:
The term "thermal validation" is the process of validating
equipment and storage facilities to prove that they will create and
maintain the temperatures they are designed for.

Calibration
:
Calibration is the process of determining the error of indication
of a measuring instrument. Calibration is performed by comparing
the instrument against an instrument of a higher accuracy with a
known error of indication. In popular terms, it can be said that
"all measuring instruments are inaccurate, a calibration determines
by how much"
.

Qualification:
Qualification is an overall term used to describe the steps in the
process of ensuring that an instrument or facility is suitable for
use as intended. This process is applied prior to commissioning of
new equipment, whenever components are replaced, during removal or
when changes to the programming are made.

Maintenance:
Preventive measures or enhancements to process equipment that
optimises its use.

cGMP:
'Current Good Manufacturing Practices' is a set of rules adhered to
by pharmaceutical and biotech companies in order to ensure that
production output meets specific requirements in terms of identity,
strength, quality, and purity. The FDA and other authorities
regulate these industries to ensure that cGMP are being
followed.